Electronic Batch Records (EBR) are systems that document and manage the production of batches of products. They are widely used in the pharmaceutical and biotechnology industries, replacing paper records and offering several advantages.
By producing items with quality and safety, companies generate records all the time. That is why batch registration — whether electronic or analog — emerged, which in this case focuses on production, analysis, maintenance, non-conformities and any data that can guarantee the traceability of the batch and evidence of its verification.
Below, you can learn more about how important these records are, what to include in your electronic batch record, and even find the most efficient way to use this tool!
What is batch registration?
The various legislations around the world require manufacturers to have proof of proper handling within all stages of the production process, especially if they work with pharmaceutical products.
For example, the U.S. Food and Drug Administration (FDA) brings in the minimum Good Manufacturing Practice (GMP) requirements that a manufacturer must meet. One of these requirements is creating and storing production and control records. The purpose of this is to ensure that products are consistently of high quality in all batches, in line with their intended use.
In other words, the batch record is a document that collects all the data and information to make a product regulated. These records compile data on materials, dates, equipment, people, analyses, inspections, labels, and events that are related to the production process of the products.
Learn more: How to continuously improve GMP processes and review SOPs
What are electronic batch records (EBR) and what are their benefits?
As you have seen, batch registration is essential to have quality and compliance in your production line. However, this presents a major challenge, especially for more robust operations.
After all, how to record all the information of the batches and ensure that traceability is working while producing valid and true records? The answer is simple: electronic batch records (EBR).
Precisely because they are digital, they simplify the tracking and management of production data. This type of tool has been widely used in regulated sectors, as this way companies can migrate from paper to virtual and modern resources. This digital transformation occurs with the implementation of electronic batch-recording software.
An electronic batch record uses several databases that capture the information recorded during the manufacture of a batch. In addition, it can be associated with a business process modeler (BPM) engine.
Thus, you can define the process to be followed at each step, ensuring that it follows the path it should take within the organization. This can be organized from the factory floor to approval by leaders and supervisors, as this tool also allows electronic and digital signatures.
In this way, by using an electronic batch system (EBR), you maintain data integrity, save time, and reduce the incidence of human error. As a result, it ensures compliance and product quality.
And you also make it easier for production to comply legally—but only if you use the right tool. Electronic records are authorized by regulatory bodies, but they must demonstrate the accomplishment of all significant steps in the manufacturing process. This includes the production, packaging, and retention of each batch of a drug.
That is, its use is fully allowed as long as the computerized system follows all the premises of its regulation. The main ones are:
- a time-stamped audit trail;
- reporting;
- electronic signature;
- safety requirements.
In Brazil, the National Health Surveillance Agency (ANVISA) does not prohibit or regulate the use of EBR. Therefore, it is understood that they are allowed if they follow the current RDC.
What to include in electronic batch records (EBR)?
However, it is not enough to understand what an electronic batch record (EBR) is and how it can help your company. It is also essential to know what should be part of your records.
Some data is extremely important and needs to be included in the main records generated by organizations. The following are some of these crucial information:
- product batch;
- production date;
- equipment used;
- people involved in the production of that batch;
- quantity and lot of each raw material used;
- calibration of equipment such as scales and thermometers;
- lot number and the quantity of any recovered or reprocessed material added to the process;
- process controls;
- cleaning of equipment, area and utensils before and after production;
- data on the distribution of the product (quantity, customer, day, time);
- information on the delivery conditions of each raw material and each sale of the product, especially on the cleanliness and structure of the vehicle used in transport;
- pest control data.
All this information does not need to be included in a single record but must be reported in such a way that all data is traceable and related. Still, there are some characteristics that all records must have to be considered valid and true:
- Attributable – Confers the cause, authorship or possession of something;
- Legible – Immediate identification, no doubt;
- Contemporaneous – Registered at the time of the occurrence;
- Original – Original, primitive and authentic;
- Accurate – Precise, accurate, improved.
With this information, QA uses batch registration to review whether the manufacturing process has followed standard operating procedures (SOPs), critical quality attributes, and process parameters that are critical (PCC).
In addition, EBR is used to investigate deviations during production in the processes of non-conformities and customer complaints.
See also: How to manage documents in an automated and effective way
Paper or EBR registration: which one to choose?
The most traditional way to prepare records is through paper. Organizations structure form templates that are periodically printed and delivered to those responsible for filling in the data according to the frequency already defined.
These documents are then verified and approved by designated persons, usually through signatures, and subsequently retained and stored. The storage time can vary, but it is usually five years after the expiration date of the product.
This entire process presents a series of possible problems that can make it difficult to validate the record and not allow batch traceability. Some of the most common are:
- Incomplete data that cannot be recovered;
- illegible documents;
- loss of registration due to wear and tear or damage;
- use of the model in old revision;
- maintain a physical space for filing;
- spending on paper and printing;
- disorganization;
- encouraging deforestation due to the large amount of paper used;
- employees without training on how to fill out the registration;
- forgetting to register or approve the registration.
These and other obstacles can cause significant delays in production and major problems in ensuring product quality, especially in audits and inspections by public health authorities. This scenario can result in complete production losses, rework or even worse in recalls and recalls.
Therefore, the adoption of EBR has been gaining more and more space, reaching the point of no longer being a market differential — but a necessity. After all, with this tool you eliminate all the above challenges and still gain agility, efficiency and modernity in your operation.
SoftExpert Excellence Suite: the best solution for using EBR
SoftExpert Excellence Suite is an all-in-one tool when it comes to assisting organizations in implementing an EBR system. Through forms and the automation of customized processes, the software ensures product compliance, improving the efficiency of activities and ensuring full data traceability.
To understand how this works in practice and learn about all the benefits of SoftExperte Excellence Suite, talk to one of our experts right now. They can help you identify the best strategies for your company with SoftExpert solutions. Contact us today!
